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Abstract:

A biopsy device includes a cannula and an inner divider wall disposed in
the cannula. The inner divider wall defines a plurality of cannula fluid
openings. The outer wall of the cannula and the inner divider wall
together define a cutter receiving lumen and a cannula vacuum lumen. The
cannula fluid openings provide fluid communication between the cutter
receiving lumen and the cannula vacuum lumen. A cutter is translatable
with respect to the cannula for severing tissue drawn into the cannula.
The cutter is operable to cover and/or uncover the cannula fluid
openings. A proximal portion of the cutter is spaced away from the inner
divider wall. A distal portion of the cutter is configured to slide
adjacent to the inner divider wall.

Claims:

1. A biopsy device comprising: a cannula having an outer wall; an inner
divider wall disposed in the cannula, wherein the inner divider wall
defines a plurality of cannula fluid openings, wherein the outer wall of
the cannula and the inner divider wall together define a cutter receiving
lumen and a cannula vacuum lumen, wherein the cannula fluid openings
provide fluid communication between the cutter receiving lumen and the
cannula vacuum lumen; and a cutter translatable with respect to the
cannula for severing tissue drawn into the cannula; wherein the cutter is
operable to at least one of cover or uncover the cannula fluid openings,
wherein a proximal portion of the cutter is spaced away from the inner
divider wall, wherein a distal portion of the cutter is configured to
slide adjacent to the inner divider wall.

2. The biopsy device of claim 1, wherein an open end passageway is
disposed between a distal end of the cutter receiving lumen and a distal
end of the cannula vacuum lumen, wherein the open end passageway is
operable to remain open after the cutter is advanced to a distal most
position at the distal end of the cutter receiving lumen, and wherein
when the cutter is advanced to the distal most position, the cutter fluid
openings are covered, and the cutter vacuum lumen is operable to provide
a pressurized force for advancement through the open end passageway and
into the cutter vacuum lumen.

3. The biopsy device of claim 1, further comprising a tissue storage
assembly comprising a sample lumen for holding tissue samples, an
adjacent vacuum lumen, and a plurality of fluid openings disposed
therebetween, the sample lumen communicating with the plurality of fluid
openings.

4. The biopsy device of claim 3, wherein the sample lumen is configured
to hold the tissue samples in end to end configuration.

5. The biopsy device of claim 3, further comprising a movable member for
sequentially uncovering the fluid openings in the tissue storage
assembly.

6. The biopsy device of claim 5, wherein movement of the movable member
is operatively associated with translation of the cutter.

7. The biopsy device of claim 6, wherein the cannula comprises a tissue
receiving port having a longitudinal length.

8. The biopsy device of claim 7, wherein the movable member is adapted to
move at least about the longitudinal length of the tissue receiving port
for each tissue sample severed.

9. A biopsy device comprising: a cannula having a tissue receiving port,
an outer wall, and an inner divider wall terminating at a proximal edge,
wherein the outer wall surrounds the inner divider wall and extends
proximally past the proximal edge of the inner divider wall; and a hollow
cutter disposed for translation with respect to the cannula for severing
tissue samples from tissue received in the tissue receiving port.

10. The biopsy device of claim 9, further comprising: a tissue storage
assembly disposed proximally of the tissue receiving port for holding the
severed tissue samples along a longitudinal line; and an apparatus for
providing a fluid pressure differential for transporting samples severed
from tissue drawn into the tissue receiving port to the tissue storage
assembly; wherein a distal end of the tissue storage assembly is operable
to fasten to or detach from a proximal end of the biopsy device.

11. The biopsy device of claim 10, further comprising a rear tube
extending proximally from the cutter, wherein a proximal end of the rear
tube comprising at least one of a fastener or a notch is operable to
removably fasten to a distal end of the tissue storage assembly
comprising at least the other of the fastener or the notch, wherein the
fastener is configured for a mating engagement with the notch.

12. The biopsy device of claim 10, wherein the tissue storage assembly is
separable from the biopsy device.

13. The biopsy device of claim 10, wherein the tissue storage assembly
comprises at least one transparent portion for permitting viewing of the
tissue samples.

14. The biopsy device of claim 10, wherein the tissue storage assembly
comprises a tissue sample tube comprising a sample lumen, and wherein at
least a portion of the tissue sample tube can be configured to expose
samples disposed in the sample lumen.

15. The biopsy device of claim 14, wherein at least a portion of the
tissue sample tube is releasable along at least a portion of the length
of the tissue sample tube to expose samples disposed in the sample lumen.

18. The biopsy device of claim 17, comprising a plurality of fluid
passageways for providing fluid communication between the at least two
generally parallel lumens.

19. A biopsy device comprising: a cannula having a tissue receiving port,
an outer wall having an inner surface, a cutter receiving lumen, a
cannula vacuum lumen having a distal portion and a proximal portion, and
an inner divider wall terminating at a proximal edge; a hollow cutter
disposed for translation with respect to the cannula for severing tissue
drawn into the tissue receiving port, wherein the proximal portion of the
cannula vacuum lumen extends proximally past the proximal edge of the
inner divider wall and is defined by the cutter and the inner surface of
the outer wall, and wherein the distal portion of the cannula vacuum
lumen extends distally past the proximal edge of the inner divider wall
and is defined by the inner divider wall and the inner surface of the
outer wall; and wherein the inner divider wall defines a plurality of
cannula fluid openings disposed between the cutter receiving lumen and
the cannula vacuum lumen, and wherein the cutter is operable to at least
one of cover or uncover the cannula fluid openings.

20. The biopsy device of claim 19, further comprising: a tissue storage
assembly in longitudinal communication with the cutter; wherein each
tissue sample stored in the tissue storage assembly may be removed for
inspection prior to severing additional tissue samples.

Description:

PRIORITY

[0001] The present application is a continuation of and claims priority to
pending U.S. patent application Ser. No. 12/778,159, which is a
Divisional of, pending U.S. patent application Ser. No. 10/953,395,
"BIOPSY DEVICE WITH SAMPLE STORAGE", filed on Sep. 29, 2004, the
disclosures of which are incorporated by reference herein.

[0003] The diagnosis and treatment of tissue is an ongoing area of
investigation. Medical devices for obtaining tissue samples for
subsequent sampling and/or testing are know in the art. For instance, a
biopsy instrument now marketed under the tradename MAMMOTOME is
commercially available from Ethicon Endo-Surgery, Inc. for use in
obtaining breast biopsy samples.

[0005] Researchers in the medical device area continue to seek new and
improved methods and devices for cutting, handling, and storing tissue
samples.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] While the specification concludes with claims which particularly
point out and distinctly claim the invention, it is believed the present
invention will be better understood from the following description of
certain examples taken in conjunction with the accompanying drawings, in
which like reference numerals identify the same elements and in which:

[0007] FIG. 1 is a partial isometric and partial schematic view of a
biopsy instrument according to one embodiment of the present invention,
which includes a handpiece for the collection of soft tissue;

[0008]FIG. 2 is an isometric view of the probe assembly separated from
the holster;

[0009]FIG. 3a is cross-sectional isometric view of the probe assembly
taken along line 3-3 in FIG. 2 with the cutter & carriage assembly
positioned at the proximal end position;

[0010]FIG. 3b is cross-sectional isometric view of the probe assembly
taken along line 3-3 in FIG. 2 with the cutter & carriage assembly
positioned between the proximal and distal end positions;

[0011]FIG. 3c is cross-sectional isometric view of the probe assembly
taken along line 3-3 in FIG. 2 with the cutter & carriage assembly
positioned at the distal end position;

[0012]FIG. 4 is an exploded isometric view of the probe assembly of FIG.
2;

[0013]FIG. 5a is a schematic diagram of the biopsy needle illustrating
the fluid forces and cutter when the cutter is in a proximal end position
at the initiation of a cutting cycle;

[0014]FIG. 5b is a schematic diagram similar to FIG. 5a, illustrating the
cutter and fluid forces as the cutter translates distally to sever a
tissue sample;

[0015]FIG. 5c is a schematic diagram similar to FIG. 5a, illustrating the
fluid forces and cutter when the cutter has closed the aperture and
severed the tissue sample;

[0016]FIG. 5d is a schematic diagram similar to FIG. 5a, illustrating the
fluid forces and cutter as the cutter has reached the distal end position
and a tissue sample is aspirated to the tissue storing assembly at the
conclusion of a cutting cycle;

[0017]FIG. 6 is an isometric view of the rotary drive shaft illustrating
a drive coupling configuration;

[0018]FIG. 7 is an isometric view of an alternative embodiment for the
cutter and drive carriage in which the cutter is removable from the probe
assembly;

[0019] FIG. 8 is an isometric view similar to FIG. 7, illustrating the
cutter and rear tube disengaged from the carriage and rotary drive gear
for removal from the probe assembly;

[0020]FIG. 9a is an isometric view of the distal end of the biopsy needle
illustrating the needle lumen and divider in greater detail;

[0021]FIG. 9b is a top isometric view of the distal portion of the biopsy
needle illustrating the side tissue receiving port in greater detail;

[0022] FIG. 10 is an isometric view of an alternative embodiment for the
biopsy needle;

[0023] FIG. 11 is an exploded isometric view of the biopsy needle shown in
FIG. 10;

[0024] FIG. 12 is a more detailed top isometric view of the aperture
component shown in FIG. 11;

[0025] FIG. 13 is a more detailed bottom isometric view of the aperture
component shown in FIG. 11;

[0026] FIG. 14 is an isometric view of a serial tissue stacking assembly;

[0027]FIG. 15a is an isometric view of the probe assembly of FIG. 2 and
the distal end of the serial tissue stacking assembly of FIG. 14, showing
connectors for attaching the serial tissue storing assembly to the probe
assembly;

[0028] FIG. 15b is an isometric view similar to FIG. 15a, illustrating the
probe assembly attached to the serial tissue storing assembly;

[0029] FIG. 16 is a side cross-sectional view taken along line 16-16 of
the serial tissue stacking assembly of FIG. 14;

[0030] FIG. 17 is a side cross-sectional view taken along line 17-17 of
FIG. 16, illustrating the vacuum communication holes of the serial tissue
stacking tube in greater detail;

[0031] FIG. 18 is an isometric view of the translating flexible rod;

[0032] FIG. 19 is an isometric view showing the reciprocating member and
lower connector in greater detail;

[0033]FIG. 20 is an isometric view showing the probe connectors and
distal end of the tissue sample storage tube in greater detail;

[0034] FIG. 21 is a detailed isometric view of the tissue retrieval
mechanism shown in FIG. 14, with the outer sleeve of the mechanism in a
closed position;

[0035]FIG. 22 is a detailed isometric view of the tissue retrieval
mechanism of FIG. 21, showing the outer sleeve of the mechanism in an
open position;

[0036]FIG. 23 is an exploded isometric view of the mechanism of FIG. 21;

[0037]FIG. 24 shows a flexible push rod in the form of a plunger for use
in removing samples;

[0039]FIG. 26a is a schematic illustration of an embodiment of a
separable tissue storage tube;

[0040]FIG. 26b is an isometric sectional view similar to FIG. 26a,
illustrating the vacuum lumen being peeled away from the tissue lumen;

[0041]FIG. 26c is an isometric view similar to FIG. 26a, illustrating the
tissue lumen removed from the vacuum lumen;

[0042]FIG. 27a is an isometric sectional view of an alternative
embodiment for a separable tissue sample storage tube;

[0043]FIG. 27b is an isometric sectional view similar to FIG. 27a,
illustrating the vacuum lumen being peeled away from the tissue lumen;

[0044]FIG. 28 is an isometric sectional view of a third embodiment for a
separable tissue storage tube in which the tissue and vacuum lumens are
separately extruded and attached together by a mechanical latch;

[0045]FIG. 29 is an isometric view of an alternative embodiment for the
serial tissue stacking assembly of FIG. 14, in which the proximal end of
the tissue lumen is attached to a tissue stop rather than the tissue
retrieval mechanism;

[0047]FIG. 31a is an isometric sectional view of the alternative serial
tissue stacking assembly embodiment shown in FIG. 29 showing the
positions of the connectors, sample tube and translating rod of the
serial tissue storing assembly when the cutter and drive carriage are
advanced distally in an initial cutting cycle;

[0048]FIG. 31b is an isometric sectional view similar to FIG. 31a,
showing the positions of the connectors, sample tube and translating rod
when the cutter and drive carriage are retracted following the initial
cutting cycle;

[0049] FIG. 31c is an isometric sectional view similar to FIG. 31a,
showing the positions of the connectors, sample tube and translating rod
of the serial tissue storing assembly when the cutter and drive carriage
are advanced distally during a second cutting cycle;

[0050] FIG. 31d is an isometric sectional view similar to FIG. 31a,
showing the positions of the connectors, sample tube and translating rod
of the serial tissue storing assembly when the cutter and drive carriage
are retracted following the second cutting cycle;

[0051]FIG. 32 is an isometric view of a parallel tissue stacking assembly
for the present invention;

[0052]FIG. 33 is an exploded isometric view of the parallel tissue
stacking assembly of FIG. 32;

[0053]FIG. 34 is a bottom isometric view of the tissue storage component
shown in FIGS. 32 and 33;

[0054] FIG. 35 is an isometric view of the distal end of the parallel
tissue stacking assembly of FIG. 32, with the tissue storage component
removed;

[0055]FIG. 36a is a more detailed isometric view of the cam member of
FIG. 33, showing the cam member in a retracted position at the beginning
of a cutting cycle, with the position of a pair of bosses shown in
phantom;

[0056]FIG. 36b is a more detailed isometric view similar to FIG. 36a,
showing the cam member in an advanced position during the cutting cycle,
and a pair of bosses in phantom, with one of the bosses deflecting the
camming surface;

[0057]FIG. 36c is a more detailed isometric view similar to FIG. 36a,
showing the cam member in a retracted position at the conclusion of a
cutting cycle, with the position of a boss at the conclusion of the
cutting cycle shown in phantom;

[0058]FIG. 37 is an exploded isometric view of a cable driven drive
assembly for the holster viewed in the proximal direction;

[0059]FIG. 38a is an isometric view of a probe assembly base unit for use
in a mammography guided biopsy procedure;

[0060] FIG. 38b is an isometric view of a probe and probe assembly base
unit for use in a mammography guided biopsy procedure;

[0061]FIG. 39 is an isometric view of a second embodiment of a probe
assembly base unit for use in an ultrasound guided biopsy procedure;

[0062]FIG. 40 is an isometric view of a third embodiment of a probe
assembly base unit for use in an MRI guided biopsy procedure; and

[0063]FIG. 41 is an isometric view of an MRI localization depth gage for
interfacing the probe assembly with an MRI unit.

[0064] The drawings are not intended to be limiting in any way, and it is
contemplated that various embodiments of the invention may be carried out
in a variety of other ways, including those not necessarily depicted in
the drawings. The accompanying drawings incorporated in and forming a
part of the specification illustrate several aspects of the present
invention, and together with the description serve to explain the
principles of the invention; it being understood, however, that this
invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[0065] The following description of certain examples of the invention
should not be used to limit the scope of the present invention. Other
examples, features, aspects, embodiments, and advantages of the invention
will become apparent to those skilled in the art from the following
description, which is by way of illustration, one of the best modes
contemplated for carrying out the invention. As will be realized, the
invention is capable of other different and obvious aspects, all without
departing from the invention. Accordingly, the drawings and descriptions
should be regarded as illustrative in nature and not restrictive.

[0066] The present disclosure pertains to a biopsy device for obtaining a
tissue sample from within a body. The biopsy device can have a reduced
cutting stroke length as compared to device such as commercially
available Mammotome brand biopsy devices. Reducing the cutting stroke
length decreases the time to acquire each sample, and also the overall
size of the biopsy device, thereby enhancing the versatility and
ergonomics of the device. The reduced stroke length of the cutter enables
many of the same probe components to be used in all three primary imaging
environments: mammography, ultrasound and MRI. In addition, the present
invention enables the sequential collection and storage of tissue
samples. Tissue samples may be removed from the biopsy device and
examined in real-time, as well as sequentially stored for subsequent
retrieval at the conclusion of the biopsy procedure. Sequentially storing
tissue samples eliminates the need to immediately remove each sample from
the device following sampling, thereby further reducing the sample
acquisition time.

[0067] FIG. 1 shows a core sampling biopsy instrument according to the
present invention comprising a handpiece identified generally as numeral
30. Handpiece 30 can be held comfortably in a single hand, and can be
manipulated with a single hand. Handpiece 30 can include a probe assembly
32 and a detachably connected holster 34. Probe assembly 32 can be
operatively connected to a vacuum source 36, such as by a first, lateral
tube 40 and a second, axial tube 42. First and second tubes 40, 42 can be
made from a flexible, transparent or translucent material, such as
silicon tubing, PVC tubing or polyethylene tubing. Using a transparent
material enables visualization of the matter flowing through tubes 40,
42.

[0068] First tube 40 can include a Y connector 44 for connecting to
multiple fluid sources. A first proximal end of Y connector 44 can extend
to a first solenoid controlled rotary valve 48 in a control module 46,
while the second proximal end of the Y connector can extend to a second
solenoid controlled rotary valve 51 in control module 46. The first
solenoid controlled rotary valve 48 in control module 46 can be operable
to connect either the vacuum source 36 or the compressed air source 38 to
lateral tube 40. It is understood within this specification that
compressed air means air pressure at or above atmospheric pressure. In
one configuration, when valve 48 is activated, vacuum is supplied to tube
40 from vacuum source 36, and when valve 48 is not activated, pressurized
air from compressed air source 38 is supplied through tube 40. The
solenoid associated with valve 48 can be controlled by a microprocessor
49 in control module 46, as indicated by dashed line 47. Microprocessor
49 can be employed to adjust the position of valve 48 automatically based
upon the position of a cutter movably supported within probe assembly 32.
The second solenoid controlled rotary valve 51 in control module 46 can
be employed to either connect a saline supply 50 (such as a saline supply
bag, or alternatively, a pressurized reservoir of saline) to a tube 188
or to seal off the proximal end of tube 188. For instance, rotary valve
51 can be activated by microprocessor 49 to supply saline when a switch
on handpiece 30 is actuated. When rotary valve 51 is activated, first
rotary valve 48 can be automatically deactivated (such as by
microprocessor 49) to prevent the interaction of vacuum and saline within
lateral tube 40. A stopcock 58 may be included in lateral vacuum tube 40
to allow for a syringe injection of saline directly into the tube 40, if
desired. For instance, a syringe injection can be employed to increase
the saline pressure in the tube to dislodge any clogs that may occur,
such as tissue clogging fluid passageways.

[0069] In one embodiment, axial vacuum tube 42 can be employed to
communicate vacuum from source 36 to probe assembly 32 through a tissue
storage assembly 52. Axial tube 42 can provide vacuum through the cutter
within probe assembly 32 to assist in prolapsing tissue into a side
tissue aperture prior to cutting. After cutting occurs, the vacuum in
axial line 42 can be employed to help draw a severed tissue sample from
probe assembly 32 and into tissue storage assembly 52, as will be
described in further detail below.

[0070] Holster 34 can include a control cord 54 for operationally
connecting handpiece 30 to control module 46, and a flexible rotatable
shaft 55 connecting the holster to a drive motor 45. A power source 56
can be employed to provide energy to control module 46 for powering
holster 34 via control cord 54. Switches 60 are mounted on holster upper
shell 62 to enable an operator to use handpiece 30 with a single hand.
One-handed operation allows the operator's other hand to be free, for
example, to hold an ultrasonic imaging device. Switches 60 can include a
two-position rocker switch 64 for manually actuating the motion of the
cutter (e.g. forward movement of the rocker switch moves the cutter in
the forward (distal) direction for tissue sampling and rearward movement
of the rocker switch actuates the cutter in the reverse (proximal)
direction). Alternatively, the cutter could be automatically actuated by
control module 46. An additional switch 66 can be provided on holster 34
for permitting the operator to activate saline flow on demand into
lateral tube 40 (for instance, switch 66 can be configured to operate
valve 51 for providing saline flow to tube 40 when switch 66 is depressed
by the user).

[0071]FIG. 2 shows probe assembly 32 disconnected from holster 34. Probe
assembly 32 includes an upper shell 70 and a lower shell 72, each of
which may be injection molded from a rigid, biocompatible plastic, such
as a polycarbonate. Upon final assembly of probe assembly 32, upper and
lower shells 70, 72 can be joined together along a joining edge 74 by any
of a number of methods well-known for joining plastic parts, including,
without limitation, ultrasonic welding, snap fasteners, interference fit,
and adhesive joining

[0072] FIGS. 3a, 3b, 3c, and 4 illustrate probe assembly 32 in greater
detail. FIG. 3a depicts the cutter assembly and carriage retracted
proximally. FIG. 3b depicts the cutter assembly and carriage partially
advanced. FIG. 3c depicts the cutter assembly and carriage advanced
distally. As shown in FIGS. 3a-c, the probe assembly can include a biopsy
needle 80 located at a distal end of probe assembly 32 for insertion into
a patient's skin to obtain a tissue sample. Needle 80 comprises an
elongated, metallic cannula 82, which can include an upper lumen, such as
an upper cutter lumen 83 for receiving a cutter 100 (as shown in FIG.
5a), and a lower lumen, such as a lower lumen 84 for providing a fluid
passageway. Cutter 100 can be disposed within cannula 82, and can be
coaxially disposed within lumen 83.

[0073] Cannula 82 can have any suitable cross-sectional shape, including a
circular or oval shaped cross-section. Adjacent and proximal of the
distal end of cannula 82 is a side (lateral) tissue receiving port 86 for
receiving the tissue to be severed from the patient. A sharpened tip of
needle 80 can be formed by a separate endpiece 90 attached to the distal
end of cannula 82. The sharpened tip of endpiece 90 can be used to pierce
the patient's skin so that the side tissue receiving port can be
positioned in the tissue mass to be sampled. Endpiece 90 can have a
two-sided, flat-shaped point as shown, or any number of other shapes
suitable for penetrating the soft tissue of the patient.

[0074] The proximal end of needle 80 can be attached to a union sleeve 92
having a longitudinal bore 94 therethrough, and a transverse opening 96
into a widened center portion of the bore. The distal end of lateral tube
40 can be inserted to fit tightly into transverse opening 96 of union
sleeve 92. This attachment allows the communication of fluids (gas or
liquid) between the lower lumen and the lateral tube 40.

[0075] The cutter 100, which can be an elongated, tubular cutter, can be
disposed at least partially within upper lumen 83, and can be supported
for translation and rotation within lumen 83. Cutter 100 can be supported
within needle lumen 84 so as to be translatable in both the distal and
proximal directions. Cutter 100 can have a sharpened distal end 106 for
cutting tissue received in upper lumen 83 through side tissue receiving
port 86. The cutter 100 may be formed of any suitable material, including
without limitation a metal, a polymer, a ceramic, or a combination of
materials. Cutter 100 can be translated within lumen 83 by a suitable
drive assembly such that distal end 106 travels from a position proximal
of the side tissue port 86 (illustrated in FIG. 3a) to a position distal
of side tissue port 86 (illustrated in FIG. 3c), in order to cut tissue
received in lumen 83 through the side tissue port 86. In an alternative
embodiment, an exterior cutter can be employed, with the exterior cutter
sliding coaxially with an inner cannular needle, and the inner needle can
include a side tissue receiving port.

[0076] Union sleeve 92 is supported between probe upper and lower shells
70, 72 to ensure proper alignment between cutter 100 and the union
sleeve. The cutter 100 can be a hollow tube, with a lumen 104 extending
axially through the length of cutter 100. As shown in FIG. 4, the
proximal end of cutter 100 can extend through an axial bore of a cutter
gear 110. Cutter gear 110 may be metallic or polymeric, and includes a
plurality of cutter gear teeth 112. Cutter gear 110 can be driven by a
rotary drive shaft 114 having a plurality of drive gear teeth 116
designed to mesh with cutter gear teeth 112. Drive gear teeth 116 can
extend along the length of drive shaft 114 so as to engage cutter gear
teeth 112 as the cutter 100 translates from a proximal most position to a
distal most position, as illustrated in FIGS. 5a-5c. Drive gear teeth 116
can be in continual engagement with cutter gear teeth 112 to rotate
cutter 100 whenever drive shaft 114 is rotatably driven. Drive shaft 114
rotates cutter 100 as the cutter advances distally through tissue
receiving port 86 for the cutting of tissue. Drive shaft 114 may be
injection molded from a rigid engineered plastic such as liquid crystal
polymer material or, alternatively, could be manufactured from a metallic
or nonmetallic material. Drive shaft 114 includes a first axial end 120
extending distally from the shaft. Axial end 120 is supported for
rotation within probe lower shell 72, such as by a bearing surface
feature 122 molded on the inside of the probe shell. Similarly, a second
axial end 124 extends proximally from rotary drive shaft 114 and is
supported in a second bearing surface feature 126 which can also be
molded on the inside of probe lower shell 72. An O-ring and bushing (not
shown) may be provided on each axial end 120, 124 to provide rotational
support and audible noise dampening of the shaft 114 when rotary drive
shaft 114 is mounted in probe shell 72.

[0077] As shown in FIGS. 3a, 3b, 3c, and 4, a drive carriage 134 is
provided in probe assembly 32 to hold cutter gear 110, and carry the
cutter gear and attached cutter 100 during translation in both the distal
and proximal directions. Drive carriage 134 is preferably molded from a
rigid polymer and has a cylindrically-shaped bore 136 extending axially
therethrough. A pair of J-shaped hook extensions 140 extend from one side
of drive carriage 134. Hook extensions 140 rotatably support cutter 100
on either side of cutter gear 110 to provide proximal and distal
translation of the cutter gear and cutter during proximal and distal
translation of drive carriage 134. Hook extensions 140 align cutter 100
and cutter gear 110 in the proper orientation for cutter gear teeth 112
to mesh with drive gear teeth 116.

[0078] Drive carriage 134 is supported on a translation shaft 142. Shaft
142 is supported generally parallel to cutter 100 and rotary drive shaft
114. Rotation of the translation shaft 142 provides translation of the
carriage 134 (and so also cutter gear 110 and cutter 100) by employing a
lead screw type drive. Shaft 142 includes an external lead screw thread
feature, such as lead screw thread 144, on its outer surface. The screw
thread 144 extends into a bore 136 in carriage 134. The screw thread 144
engages an internal helical threaded surface feature provided on the
inner surface of bore 136. Accordingly, as shaft 142 is rotated, the
carriage 134 translates along the threaded feature 144 of the shaft 142.
The cutter gear 110 and the cutter 100 translate with the carriage 134.
Reversing the direction of rotation of shaft 142 reverses the direction
of translation of the carriage 134 and the cutter 100. Translation shaft
142 may be injection molded from a rigid engineered plastic such as
liquid crystal polymer material or, alternatively, could be manufactured
from a metallic or non-metallic material. Translation shaft 142 with lead
screw thread feature 144 can be molded, machined, or otherwise formed.
Likewise, carriage 134 can be molded or machined to include an internal
helical thread in bore 136. Rotation of shaft 142 drives the carriage and
cutter gear 110 and cutter 100 in the distal and proximal directions,
depending upon the direction of rotation of shaft 142, so that cutter 100
translates within probe assembly 32. Cutter gear 110 is rigidly attached
to cutter 100 so that the cutter translates in the same direction and at
the same speed as drive carriage 134.

[0079] In one embodiment, at the distal and proximal ends of lead screw
thread 144, the helical thread is cut short so that the effective pitch
width of the thread is zero. At these distal most and proximal most
positions of thread 144, translation of drive carriage 134 is no longer
positively driven by shaft 142 regardless of the continued rotation of
shaft 142, as the carriage effectively runs off the thread 144. Biasing
members, such as compression coil springs 150A and 150B (FIGS. 3a-c), are
positioned on shaft 142 adjacent the distal and proximal ends of the
screw thread 144. Springs 150A/B bias carriage 134 back into engagement
with lead screw thread 144 when the carriage runs off the thread 144.
While shaft 142 continues rotating in the same direction, the zero pitch
width thread in combination with springs 150A/B cause carriage 134 and,
therefore, cutter 100 to "freewheel" at the end of the shaft. At the
proximal end of the threaded portion of shaft 142, the carriage engages
spring 150A. At the distal end of the threaded portion of shaft 142, the
carriage engages spring 150B. When the carriage runs off the screw thread
144, the spring 150A or 150B engages the carriage 134 and biases the
carriage 134 back into engagement with the screw thread 144 of shaft 142,
at which point continued rotation of the shaft 142 again causes the
carriage 134 to run off the screw thread 144. Accordingly, as long as
rotation of shaft 142 is maintained in the same direction, the carriage
134 (and cutter 100) will continue to "freewheel", with the distal end of
the cutter 106 translating a short distance proximally and distally as
the carriage is alternately biased onto the thread 144 by spring 150A or
150B and then run off the screw thread 144 by rotation of shaft 142. When
the cutter is in the distal most position shown in FIG. 3c, with the
distal end 106 of cutter positioned distal of side tissue port 86, spring
150B will engage carriage 134, and repeatedly urge carriage 134 back into
engagement with screw thread 144 when carriage 134 runs off the screw
thread 144. Accordingly, after the cutter 100 is advanced such that the
distal end 106 of the cutter translates distally past the side tissue
port 86 to cut tissue, to the position shown in FIG. 3c, continued
rotation of the shaft 142 will result in the distal end 106 oscillating
back and forth, translating a short distance proximally and distally,
until the direction of rotation of shaft 142 is reversed (such as to
retract the cutter 100 distally to the position shown in FIG. 3a.) The
slight movement of carriage 134 into engagement with the screw thread and
out of engagement with the screw thread 144 against the biasing force of
spring 150B, causes the distal end 106 of cutter 100 to repetitively
reciprocate a short distance within cannula 82, which distance can be
about equal to the pitch of threads 144, and which distance is shorter
than the distance the cutter travels in crossing the side tissue port 86.
This reciprocal movement of the cutter can provide alternate covering and
uncovering of at least one fluid passageway disposed distally of the side
tissue port, as described below.

[0080] The zero pitch width ends of lead screw thread 144 provide a
defined stop for the axial translation of cutter 100, thereby eliminating
the need to slow carriage 134 (i.e. cutter 100) as it approaches the
distal and proximal ends of the thread. This defined stop reduces the
required positioning accuracy for carriage 134 relative to shaft 142,
resulting in reduced calibration time at the initialization of a
procedure. The freewheeling of carriage 134 at the distal and proximal
most positions of translation shaft 142 eliminates the need to rotate the
shaft a precise number of turns during a procedure. Rather, translation
shaft 142 only needs to translate at least a minimum number of turns to
insure carriage 134 has translated the entire length of lead screw thread
144 and into the zero width thread.

[0081] Additionally, the freewheeling of carriage 134 eliminates the need
to home the device, allowing probe assembly 32 to be inserted into the
patient's tissue without first being attached to holster 34. After probe
assembly 32 is inserted, holster 34 is attached and sampling can be
commenced.

[0082] As shown in FIG. 4, a non-rotating rear tube 152 can be provided
which tube 152 can extend proximally from the proximal end of cutter 100
just proximal of cutter gear 110. Rear tube 152 can be hollow and can
have substantially the same inner diameter as cutter 100, and may be
comprised of the same material as the cutter. A seal 154 can be
positioned between cutter 100 and rear tube 152 to enable the cutter to
rotate relative to the tube while providing a pneumatic seal between the
rear tube 152 and the cutter 100. A rear lumen 156 can extend through the
length of tube 152 and can be aligned with lumen 104 in cutter 100. Rear
lumen 156 transports excised tissue samples from lumen 104 through probe
assembly 32 to the tissue storage assembly 52. Lumen 104 and rear lumen
156 are axially aligned to provide a continuous, generally straight line,
unobstructed passageway between tissue receiving port 86 and tissue
storage assembly 52 for the transport of tissue samples. The inner
surfaces of cutter 100 and tube 152 may be coated with a hydrolubricous
material to aid in the proximal transport of the excised tissue samples.

[0083] A lateral extension 158 can be provided and can be supported by and
extend distally from rear tube 152 for securing the tube to drive
carriage 134. The extension 158 connects tube 152 to carriage 134 so that
tube 152 translates with cutter 100, and maintains lumens 104, 156 in
continuous fluid-tight communication throughout the cutting cycle.

[0084] FIGS. 5a-5d provide simplified schematic views of the movement of
cutter 100 during a cutting cycle. As shown in FIG. 5a, initially in the
cutting cycle cutter 100 is located at a proximal most position with
distal cutting end 106 disposed proximally of the proximal most edge of
the side tissue port 86, and adjacent the proximal end of a lumen divider
170. As the cutting cycle begins, a lateral vacuum force (indicated by
arrow 176) can be provided in lower lumen 84. Vacuum force 176 can be
transmitted from vacuum source 36 through tube 40 to lower lumen 84
through a flow path provided by union sleeve 92.

[0085] Microprocessor 49 can be employed to activate valve 48 to supply
vacuum force 176 when switch 64 is actuated by the user to begin moving
cutter 100 distally within needle 80. Lateral vacuum force 176
communicates with tissue receiving port 86 through fluid passageways 172
disposed under port 86, and through one or more fluid passageways 174
disposed distally of the port 86. In FIG. 5c, a fluid passageway 174A is
illustrated disposed distally of port 86 and spaced approximately 180
degrees circumferentially from port 86. In FIG. 5d, a fluid passageway
174B is illustrated disposed distally of the port 86 in the distal
endpiece 90 of the biopsy probe. Both fluid passageways 174A and 174B can
provide fluid communication between lower lumen 84 and upper lumen 83.

[0086] Lateral vacuum force 176 can be employed in combination with an
axial vacuum force 180 through cutter lumen 104 to draw a tissue sample
182 into tissue port 86. After tissue sample 182 is drawn into port 86,
cutter 100 can be rotated and simultaneously translated distally to sever
the tissue sample from the surrounding tissue. While cutter 100 advances,
vacuum forces 176, 180 can be maintained through lower lumen 84 and
cutter lumen 104 to draw the tissue sample into the cutter lumen as the
sample is severed. As shown in FIG. 5b, as cutter 100 advances the cutter
slides across fluid passageways 172, successively blocking the lateral
vacuum through the holes.

[0087] When cutter 100 reaches the distal most position, as shown in FIG.
5c, fluid passageways 172 can be completely blocked by the cutter. At
this point in the cutting cycle, cutter rotation can be maintained, and
the cutter can "freewheel" as described above, with the distal end 106 of
the cutter 100 moving proximally and distally in an alternating,
oscillating manner. As cutter 100 freewheels, the cutter can oscillate
distally and proximally a distance which can be about equal to the pitch
of lead screw thread 144 at a frequency corresponding approximately to
the rotation speed of translation shaft 142. One or more fluid
passageways 174A can be positioned in lumen divider 170 such that as
cutter 100 is freewheeling at its distal most position, the cutter
alternately covers and uncovers (and so opens and closes) the passageways
174A. With passageway 174A open, lower lumen 84 remains in fluid
communication with cutter lumen 104 through divider 170 despite the
blocking of passageways 172. The repetitive movement of cutter 100 over
passageway 174A can assist in clearing any tissue that may be blocking or
clogging passageway 174A, and to maintain fluid communication through
passageway 174A.

[0088] Fluid Passageway 174B in distal endpiece 90 can be employed in
place of or in combination with fluid passageway 174A. Fluid passageway
174B can provide fluid communication between lower lumen 84 and upper
lumen 83 when passageway 174 is covered by cutter 100.

[0089] A predefined amount of time after the cutter 100 reaches its distal
most position and begins to freewheel, the solenoid on rotary valve 48
can be deenergized or otherwise controlled by microprocessor 49 to
replace lateral vacuum force 176 with forward pressurized air (either
atmospheric or greater) as shown by the arrows in FIG. 5c. The
pressurized air is discharged through lateral tube 40 to lumen 84. With
port holes 172 closed off by cutter 100, the pressurized air communicates
with upper lumen 83 through fluid passageway 174A (and/or a 174B) to
apply a force against the distal face of sample 182. The force acting on
the distal face of sample 182 can act in combination with an axial vacuum
force 180 provided through the lumen 104 of cutter 100. The push provided
by the force acting on the distal face of the sample 182 in combination
with the vacuum "pull" provided by the vacuum provided via the lumen 104
of cutter 100 can be employed to move the sample 182 into and through
lumen 104 of cutter 100, as shown in FIG. 5d. Alternatively, instead of
employing pressurized air to provide a force on the distal face of sample
182, a pressurized liquid, such as saline, can be directed through lower
lumen 84 and fluid passageways 174A and/or 174B to provide the force on
the distal face of sample 182. The cutter 100 closes the side tissue port
86 from the flow of fluid (gas or liquid) so that tissue surrounding the
outer cannula and side port 86 is not exposed to the fluid.

[0090] As the tissue sample 182 translates proximally through probe
assembly 32 towards sample collection assembly 52, the cutter 100 can be
maintained in a distal most position. Alternatively, the cutter 100 can
be retracted back through tissue port 86 towards its initial position in
preparation for the next cutting cycle. After cutter 100 is fully
retracted, and the tissue sample is translated to tissue storage assembly
52, lateral vacuum force 176 is again provided via lumen 84 to draw the
next tissue sample into port 86. During the translation of cutter 100,
the cutter can operate in conjunction with divider 170 to separate lumen
83 from lumen 84.

[0091] During the cutting cycle, cutter 100 translates from a point just
proximal of side tissue receiving port 86 to a point just distal of the
receiving port. The severed tissue samples are directed through the
length of the lumen 104 of cutter 100 and out of the proximal end of the
cutter 100, rather than translating the cutter (with the samples carried
in the distal end of the cutter) proximally through the needle 80 to
eject the samples with a knock-out pin, as in some prior devices.
Accordingly, the cutting stroke length can be reduced to be just slightly
longer than the length of the side tissue port 86. With the reduced
stroke length, the distal end of the cutter 100 (as well as a length of
the cutter 100) can remain within needle 80 throughout the cutting cycle,
eliminating the need to accommodate the full length of the cutter within
the probe housing and proximal of the needle 80. In addition, the reduced
cutting stroke length reduces the required length of translation shaft
142, since the shaft need only translate the cutter a distance slightly
longer than the length of tissue receiving port 86. Reducing the
translation shaft length, and eliminating the need to accommodate the
cutter length within the probe housing, enables the length of handpiece
30 to be reduced. The time to acquire each tissue sample is also reduced
in the present invention, due to the shortened cutting stroke reducing
the time required to advance and retract the cutter through needle 80.
Since cutter 100 retracts only to a point just proximal of tissue
receiving port 86, lumen divider 170 can be formed to extend to the
proximal most point of the cutter, rather than through the entire length
of the needle. Reducing the length of divider 170 reduces the required
materials and cost of manufacturing needle 80.

[0092] As described above, fluid passageways 174A and/or 174B can also be
used to apply saline to the distal face of a severed tissue sample, such
as illustrated in FIGS. 5C-D. The saline may be used to provide a push
against the tissue sample and thereby aid in moving the tissue sample
proximally within the cutter lumen 104. To provide a saline flush, tubing
from saline supply bag 50 is routed through rotary valve 51 by control
module 46 to Y connector 44 and through lateral tube 40 to lumen 84. In
one embodiment, a button can be provided on handpiece 30, such that when
the button is depressed while the cutter is freewheeling in its distal
most position, the valve 51 is activated to connect the saline 50 to
lateral tube 40. Prior to a sampling procedure, the saline system may be
primed by activating the rotary valve 51 to allow the vacuum from vacuum
source 36 to draw saline into tubing 188. Saline will then fill tubing
188 up to Y connector 44. When the operator then depresses the handpiece
button during the procedure, the saline will flow from Y connector 44,
through lateral tube 40, and into lumen 84 to be applied against tissue
sample 182. When rotary valve 51 is deenergized, tubing 188 is sealed off
so that the flow of saline to lumen 84 is stopped.

[0093] In an alternative embodiment, saline can be automatically provided
to lumen 84 during every cutting cycle. In this embodiment, a handpiece
button is not required to operate the saline. Rather, microprocessor 49
automatically activates rotary valve 51 a designated time after cutter
100 reaches the distal most position within needle 80 during the cutting
cycle, and deactivates the valve when the cutter has retracted to a
designated proximal position. A position sensor can be incorporated with
the holster 34 or control module 46 to activate rotary valve 51 based
upon the axial position of the cutter in the cutting cycle. Thus, the
position of the cutter 100 will automatically activate and deactivate
rotary valve 51, such as when the cutter advances and retracts during
each cutting cycle.

[0094] As shown in FIG. 4, a drive slot 132 may be formed in proximal end
124 of shaft 114 for interfacing with a similar-shaped drive slot in a
motor drive shaft, or other rotary drive input from holster 34.
Alternatively, as shown in FIG. 6, a star-shaped interface 130 may be
molded into second axial end 124 of drive shaft 114. Star interface 130
can be provided to mate with a similar-shaped male interface which could
be provided on the rotary drive shaft of holster 34 to rotate drive shaft
114. Alternatively, the female star interface 130 may be molded into the
drive shaft from holster 34 and a similar-shaped male interface formed in
drive shaft 114. Use of star interface 130, or another similar type of
interface that is molded into the rotary drive shaft, minimizes the axial
length required for the drive coupling. Reducing the drive coupling
length reduces the overall length of probe 32.

[0095] FIGS. 7 and 8 illustrate an alternative embodiment for the
invention, in which cutter 100 and rear tube 152 are releasable from
probe assembly 32 such that the cutter 100 can be repeatedly removed and
re-inserted into the probe assembly 32 without disassembling the probe
assembly 32. Removal (either partial or complete removal) of the cutter
100 can be advantageous, such as where the cutter 100 is formed of metal
and the imaging device employed with the probe 32 is a Magnetic Resonance
Imaging (MRI) device. In FIGS. 7 and 8, the proximal portion of rear tube
152 is not shown.

[0096] In the embodiment shown in FIGS. 7 and 8, cutter 100 and rear tube
152 can be joined at a seal 154 just proximal of cutter gear 110, such
that the cutter is capable of rotating relative to the rear tube 152
(which can be supported to not rotate). A cutter release lever 160 can be
supported on and can protrude from rear tube 152. Release lever 160 as
shown includes an end 162 extending distally towards carriage 134. A
lateral slot 164 in end 162 is shaped and sized to engage a feature
associated with carriage 134, such as a disk feature 166 which can be
securely attached to a proximal hook extension 140 of carriage 134. While
slot 164 engages disk 166, cutter 100 and rear tube 152 translate
together with carriage 134. A spline features 168 located near the
proximal end of cutter 100 can be employed to engage with a complimenting
spline feature on the internal diameter of cutter gear 110 to insure the
cutter 100 and cutter gear 110 rotate together.

[0097] To remove cutter 100 and tube 152 from probe assembly 32, such as
for imaging prior to a cutting cycle, the proximal end of release lever
160 is squeezed in the direction of tube 152. The squeezing action
unlatches slot 164 from disk 166, releasing cutter 100 and tube 152 from
both the carriage 134 and the cutter gear 110. As shown in FIG. 8, after
tube 152 and cutter 100 are released, the tube and cutter may be pulled
proximally through the cutter gear bore and out the proximal end of probe
assembly 32. To reinsert cutter 100 and tube 152, the tube and cutter are
connected at seal 154, and the combination is inserted through the
proximal end of probe assembly 32 so that the cutter again extends
through the cutter gear bore and union sleeve bore 94 into cannula 82.
Cutter 100 and tube 152 are pushed distally through probe assembly 32
until slot 164 of end 162 again latches onto disk 166.

[0098] The cutter 100 may be repeatedly removed from and reinserted into
the probe assembly 32 through an opening in the proximal end of the probe
assembly 32. The tissue receiving port 86 can be positioned in tissue to
be sampled, the cutter 100 can be removed from the probe assembly 32, the
biopsy site can be imaged, such as by using MRI, the cutter can be
inserted into the probe assembly 32, and the tissue received in the side
tissue port 86 can be severed with the cutter 100. The step of removing
the cutter from the probe assembly can be performed before or after the
tissue port 86 is positioned within the tissue to be sampled.
Additionally, the cutter can be removed after a tissue sample is severed,
either before or after the needle 80 is removed from tissue.

[0099] As shown in FIGS. 9a and 9b, a divider 170 may be inserted in the
distal end of cannula 82 to separate the interior of needle 80 into upper
and lower lumens 83/84. In the embodiment shown in FIGS. 9a and 9b,
divider 170 extends axially through cannula 82 to a point just proximal
of tissue receiving port 86. The proximal end of divider 170 can coincide
with the proximal most position of cutter 100 so that the cutter and
divider combine to separate the upper and lower lumens. Alternatively,
divider 170 could extend axially through the full length of needle 80. As
shown in FIG. 9a, divider 170 can comprise a curved surface that conforms
closely to the outer circumference of cutter 100 to enable the cutter to
slide along the surface of the divider as the cutter translates within
cannula 82. A plurality of fluid passageway holes 172 can be formed in
divider 170 beneath tissue receiving port 86 (spaced approximately 180
degrees from the port 86). Fluid passageways 172 can be sized to permit
fluid communication between lumens 83 and 84 (and tissue receiving port
86), while preventing excised tissue portions from passing into the
lumen. Divider 170 can also include one or more fluid passageways 174
distal of the tissue receiving port 86 through which compressed gas (e.g.
air) or liquid (e.g. saline) can be provided to the distal face of a
tissue sample located within the cutter lumen 104 while the cutter 100 is
in its distal most position closing off the tissue receiving port 86.
With cutter 100 in the distal most position and closing off the tissue
receiving port 86, tissue samples can be pushed through the cutter 100
without exposing tissue surrounding the cannula 82 to the fluid. Divider
170 may be formed of the same material as cannula 82, and the
longitudinal edge of the divider may be welded or otherwise permanently
affixed to the inner diameter of the cannula.

[0100] FIGS. 10 and 11 illustrate an alternative embodiment for a biopsy
needle suitable for use with a probe assembly 32. The needle, designated
by numeral 165, can be assembled from an aperture component, a tissue
piercing component, and a tube component. In this embodiment, tube
component 168 comprises a cannula 171 having a lumen 173 extending there
through, and a tissue receiving aperture 175 adjacent the distal end of
the tube. The aperture component 177 comprises an aperture 178 and fluid
passageways 179. The tissue piercing component 90 can be insert molded
into the aperture component or mechanically secured to it, such as with
adhesive or other suitable bonding means.

[0101] As shown in greater detail in FIGS. 12 and 13, aperture component
177 can have a semi-tubular shape with an upper opening 178 of
substantially the same length as tissue receiving aperture 175. Opening
178 aligns with tissue receiving aperture 175 when the two components
168, 177 are assembled together. A plurality of fluid passageways 179 are
formed in a lower surface 169 of aperture component 177 beneath opening
178. Lower surface 169 can provide a divider for providing a lower lumen
when needle 165 is assembled. One or more fluid passageways 181 can be
provided distal of opening 178 so as to be distal of tissue receiving
aperture 175 when the needle components are assembled together.
Passageways 179 and 181 provide flow communication for compressed fluid
(e.g. air and/or saline) from the lower lumen to the upper lumen when
needle components 168, 177 are assembled together. A pair of engagement
bosses 183 can be provided and can extend from the proximal end of
aperture component 177 for attaching the aperture component to tube
component 168. To assemble needle 165, aperture component 177 is inserted
through the distal end of cannula 171 until bosses 183 engage
complimentary grooves or holes on the inner diameter of the tube
component 168. The engagement between the bosses and grooves locks
aperture component 177 within tube component 168. In addition, when
needle 165 is assembled into probe assembly 32, the portion of the cutter
100 which extends distally beyond bosses 183 in tube component 168 can
further prevent the aperture component 177 from disengaging form the tube
component 168. A circumferential lip 185 can be provided on the aperture
component 177. The lip 185 can provide a seating surface for the distal
end of tube component 168 when the aperture component is assembled with
the tube component.

[0102] Referring again to FIG. 5, once a tissue sample enters the lumen
104 of cutter 100, the axial vacuum force 180 can serve to pull the
sample proximally through the cutter 100 to be directed from probe
assembly 32 into tissue storage assembly 52. In a first embodiment,
tissue storage assembly 52 comprises a serial tissue stacking assembly
190, such as is shown in FIG. 14. In serial tissue stacking assembly 190,
multiple tissue samples are stacked one behind the next in an end to end
configuration, such as in a flexible tube. The samples may be removed
individually from the tube and examined in real-time during the procedure
or, alternatively, left in the tube until the end of the procedure and
removed all at once. The distal end of serial tissue assembly 190 can be
detachably connected via dual connection mechanisms to probe assembly 32
(so that the serial tissue storage assembly 190 is releasable from the
probe assembly), while the proximal end of the assembly 190 can be
detachably connected via tube 42 to a vacuum source, such as vacuum
source 36 shown in FIG. 1.

[0103] In the embodiment shown in FIGS. 15a and 15b, an upper connector
192 at the distal end of serial tissue assembly 190 includes a pair of
snap fasteners 194. Fasteners 194 engage a pair of fastener engaging
features 196 that are disposed at the proximal end of the probe assembly,
such as a pair of notches that can be formed in a portion of the proximal
end of probe lower shell 72. When fasteners 194 are engaged with features
196, as shown in FIG. 15a, the upper portion of serial tissue assembly
190 is attached to the probe housing.

[0104] A second, lower connecter 198, also at the distal end of serial
tissue assembly 190, can include a similar pair of snap fasteners 200.
Lower snap fasteners 200 engage a mating pair of features 202 on the
proximal end of the rear tube 152 that is shown extending from a proximal
opening in probe assembly 32 in FIG. 15b. The distal end of rear tube 152
can be joined to carriage 134 as shown in FIG. 8. When lower snap
fasteners 200 engage notches 202, as shown in FIG. 15b, the lower portion
of serial tissue assembly 190 moves distally and proximally with the
translation of drive carriage 134. When both upper connector 192 and
lower connector 198 are attached to probe assembly 32, the lower portion
of serial tissue assembly 190 will translate relative to the fixed upper
portion of the assembly during the cutting cycle. To detach serial tissue
assembly 190 from probe assembly 32, each of the pairs of snap fasteners
194, 200 are pushed inwardly at the distal ends to disengage the forward
tips of the fasteners from the corresponding notches 196, 202. After the
fasteners are disengaged, serial tissue assembly 190 may be separated
from probe assembly 32.

[0105] As shown in FIGS. 14 and 16, serial tissue assembly 190 includes a
sample storage tube 206 having dual lumens extending axially
therethrough. The dual lumens can be generally parallel. Tube 206 may be
comprised of polyvinyl chloride or another similar type of flexible,
water insoluble material. Using a clear material for storage tube 206,
such as polyvinyl chloride, enables the stacked tissue samples to be
visible from outside the tube.

[0106] Tube 206 can include a longitudinally extending center wall divider
for separating the two lumens. Tube 206 can comprise a first lumen, such
as stacking lumen 210, for transferring and storing tissue samples 204
that have been aspirated to the assembly through cutter lumen 104. Tissue
stacking lumen 210 can be detachably connected to the proximal end of
rear tube 152 by lower connector 198. When fasteners 200 engage features
202, as described above, tissue stacking lumen 210 can be axially aligned
with rear tube lumen 156 to provide a continuous, unobstructed passageway
for the movement of tissue samples 204 from tissue receiving port 86 into
the tissue lumen stacking lumen 210.

[0107] As tissue samples 204 enter tissue stacking lumen 210, the samples
stack serially one behind the next within the lumen, in end to end
configuration, as shown in FIG. 16, so that the order of the samples (the
order in which the samples are obtained from the biopsy site) is
maintained while the samples are stored in tissue stacking lumen 210. A
tissue stop can be located within the tissue retrieval mechanism 260 at
the proximal end of tissue lumen 210 to prevent the first or earliest
sample from translating completely through the tissue lumen and into
vacuum system 36. The tube 206 can comprise a second lumen, tissue
stacking vacuum lumen 214, for providing a flow communication path for
vacuum through rear tube 152 and cutter 100 so that severed tissue
samples 204 can be drawn through cutter 100 and rear tube 152 into tissue
stacking lumen 210. The proximal end of tissue stacking vacuum lumen 214
can be detachably connected to vacuum source 36 through a lateral
attachment port 216.

[0108] As shown in greater detail in FIG. 17, a plurality of small holes
220 can be provided in the center wall divider of tube 206 between lumen
214 and lumen 210 to provide flow communication between the lumens. Holes
220 enable vacuum from source 36 to be communicated from lumen 214 into
lumen 210, to provide vacuum in lumen 104 of cutter 100. Holes 220 are
preferably spaced along the longitudinal axis of tube 206 and separated
by a distance in the range of 0.1 to 4 centimeters. Holes 220 may be
oriented at an angle relative to the longitudinal axis of tube 206. The
angle in holes 220 can function as a mechanical diode, in that the edge
of the holes 220 opening into lumen 210 can aid in preventing motion of
tissue samples in a distal direction, while permitting tissue samples to
move proximally in lumen 210 under vacuum force provided by vacuum source
36. A tissue sample will continue to slide proximally through the lumen
210 until the sample contacts either the tissue stop within the tissue
retrieval mechanism 260 or a preceding tissue sample.

[0109] Vacuum holes 220 may be formed between lumens 210, 214 by boring
into the upper surface of tube 206 with the sharpened tip of a drill or
other appropriate instrument. The tip of the drill bit or other boring
instrument can be directed to pass through vacuum lumen 214 to penetrate
the center wall of tube 206 that separates the two lumens. As shown in
FIG. 14, an outer sleeve 228 is securely attached to the surface of tube
206 following the formation of vacuum communication holes 220. Outer
sleeve 228 may be attached to tube 206 by an adhesive or other
appropriate type of attachment mechanism. Outer sleeve 228 is attached to
sample tube 206 over the openings used to form vacuum communication holes
220 to seal the openings, and prevent vacuum from passing out of vacuum
lumen 214 through the openings. The distal end of outer sleeve 228 can be
formed to extend beyond the distal end of vacuum lumen 214 to connect
with upper connector 192. Vacuum lumen 214 attaches to probe assembly 32
through the connection between outer sleeve 228 and upper connector 192.

[0110] As tissue samples 204 are stored in lumen 210, the stack of samples
204 will grow in length distally in lumen 210. The samples 204 will tend
to block or otherwise restrict flow communication through vacuum holes
220 as the stack of samples extends distally in lumen 210. In FIG. 16, a
translating flexible rod 230 is shown disposed at least partially in
lumen 214. Rod 230 can extend axially through lumen 214 to selectively
cover or otherwise block at least some of the vacuum holes 220. Rod 230
can then be manipulated, such as by axial movement of rod 230, to
selectively expose vacuum holes 220 in the vacuum lumen. For instance,
during each cutting cycle, rod 230 can be advanced distally within vacuum
lumen 214 to expose or otherwise unblock/open additional vacuum holes 220
as additional samples are stored in lumen 210. The movement of rod 230
maintains a predetermined number of vacuum holes 220 open to provide flow
communication between lumens 210 and 214 as additional tissue samples are
added to the stack of tissue samples in lumen 210. This can aid in
providing a consistent vacuum force in cutter lumen 104 throughout
multiple cutting cycles. Initially, flexible rod 230 can be inserted
within lumen 214 such that rod 230 is axially offset within lumen 214 so
as to cover or otherwise block most, but not all, of the holes 220. For
instance, prior to storing any samples in lumen 214, rod 230 can be
offset distally within vacuum lumen 214 a distance that is slightly
longer than the length of tissue receiving port 86. Offsetting rod 230
distally within lumen 210 ensures an initial set of holes 220 are exposed
to communicate axial vacuum force 180 to tissue receiving port 86 when
cutter 100 is in the fully proximal position prior to tissue sampling.
The axial vacuum force communicated through the exposed holes 220 aids in
prolapsing tissue into receiving port 86 prior to cutting, as well as
pulling the tissue sample proximally into tissue lumen 210 after cutting.
As a tissue sample is drawn into and stacked within tissue lumen 210, the
tissue sample blocks the previously exposed vacuum holes 220, preventing
vacuum from passing into the tissue lumen. Rod 230 can be selectively
moved a predetermined distance distally that is slightly longer than the
length of tissue receiving port 86 to expose additional vacuum holes 220
immediately distal of the most recently acquired tissue sample. Rod 230
can be adapted to be automatically advanced distally by the translation
of drive carriage 134 within probe assembly 32, as described further
below. The newly exposed vacuum holes 220 continue the communication of
vacuum force 180 into tissue lumen 210 for the next cutting cycle.

[0111] Rod 230 can be formed of a fluoropolymer resin material such as
Teflon® or other suitable flexible material having a low coefficient
of friction. Rod 230 can be sized and shaped to conform closely to the
inner diameter of vacuum lumen 214. The close fit between rod 230 and
vacuum lumen 214, as well as the low friction properties of the rod,
enable the rod to translate easily within the vacuum lumen without any
loss of vacuum force through the distal end of the lumen.

[0112] The distal end 231 of rod 230 extends outside of vacuum lumen 214
through an opening 234 in outer sleeve 228. As rod 230 is advanced
distally, the rod moves further out of vacuum lumen 214 through opening
234. The flexibility of rod 230 allows the rod to flex out of opening 234
in outer sleeve 228 as the rod is continually advanced distally, enabling
substantially the entire rod to be translated out of vacuum lumen 214
over the course of multiple cutting cycles. As shown in greater detail in
FIG. 18, rod 230 can include a plurality of side ratchet teeth 232 spaced
longitudinally substantially along the length of the rod. Teeth 232
provide a mechanism to grip and advance rod 230 through vacuum lumen 214.
Rod 230 can also include a plurality of bottom ratchet teeth 238.

[0113] Rod 230 can be advanced distally within vacuum lumen 214 by the
interaction between teeth 232 and a pawl-type latching mechanism 240 on a
reciprocating member 242, which is shown in greater detail in FIG. 19.
Reciprocating member 242 can be supported on lower connector 198 and
reciprocates as cutter 100 is advanced and retracted. Reciprocating
member 242 can have a bifurcated proximal end with proximally extending
portions 243 separated by an axially extending slot 244. A ramped surface
246 can be formed between portions 243 at a distal end of slot 244.
Ramped surface 246 can serve to deflect the distal end 231 of rod 230
through opening 234 and alongside the outer surface of tube 206 as the
rod is ratcheted out of vacuum lumen 214. Unidirectional engagement pawls
250 can be formed to extend from the sides of portions 243 facing slot
244 to engage side ratchet teeth 232 on rod 230 as the rod extends
through the groove. The engagement between pawls 250 and ratchet teeth
232 advances rod 230 distally through vacuum lumen 214.

[0114] The distal end of reciprocating member 242 can be fixed to lower
connector 198 for translation along with the lower connector 198,
carriage 134, and cutter 100 during each cutting cycle. As drive carriage
134 advances distally at the beginning of a cutting cycle to move cutter
100 into receiving port 86, reciprocating member 242 also advances
distally. As reciprocating member 242 advances, pawls 250 in groove 244
engage side teeth 232 on rod 230 in lumen 214 to pull the rod distally
with the reciprocating member. As rod 230 moves distally within lumen
214, additional vacuum holes 220 are exposed. As the direction of
carriage 134 reverses, and cutter 100 retracts from receiving port 86,
reciprocating member 242 moves in a proximal direction relative to the
fixed vacuum lumen 214. As reciprocating member 242 retracts proximally,
unidirectional bottom ratchet teeth 238 located on the bottom side of
flexible rod 230 engage vacuum holes 220 within vacuum lumen 214 as shown
in FIG. 17. The engagement between the ratchet teeth and holes 220
prevents rod 230 from moving proximally within vacuum lumen 214. As pawls
250 move proximally relative to rod 230, the pawls engage the next
proximal set of ratchet teeth 232 on rod 230. This engagement with the
next set of ratchet teeth 232 causes rod 230 to again advance distally
when drive carriage 134 advances distally during the next cutting cycle
to expose additional vacuum communication holes 220. In the event that
the carriage and cutter assembly is advanced and retracted without the
probe assembly 32 in tissue, resulting in the flexible rod 230 advanced
too far distally relative to the tissue samples 204; the flexible rod 230
can be rotated a fraction of a turn about its longitudinal axis to
disengage ratchet teeth 232 and 238 allowing the flexible rod 230 to be
repositioned proximally within the vacuum lumen 214.

[0115] In an alternative embodiment not shown, flexible rod 230 could be
advanced distally within vacuum lumen 214 as drive carriage 134 is
retracted proximally following the cutting of tissue. In this embodiment,
a reversing mechanism such as, for example, a cable extending 180°
degrees around a pulley, could be utilized so that as the drive carriage
retracts the cable pulls the flexible rod distally.

[0117]FIG. 20 illustrates in greater detail connectors 192, 198 and
lumens 210, 214. As shown in FIG. 20, vacuum lumen 214 can be attached to
fixed upper connector 192 by outer sleeve 228. Vacuum lumen 214 thus
remains fixed in position within serial tissue assembly 190 throughout
the cutting cycle. Tissue lumen 210 extends distally into bore 252 of
lower connector 198. At least a distal portion of tissue lumen 210 will
translate along with lower connector 198 and drive carriage 134 during
each cutting cycle. As drive carriage 134 and lower connector 198
translates proximally, a distal portion 211 of the sample tube including
the distal portion of tissue lumen 210 flexes or otherwise deforms
downward, enabling the distal end of the tissue lumen to translate along
with lower connector 198 and reciprocating member 242, while vacuum lumen
214 remains fixed in position by outer sleeve 228.

[0118] As shown in FIGS. 14 and 16 a tissue retrieval mechanism 260 may be
located at the proximal end of serial tissue assembly 190 for removing
samples from the assembly in real-time following each cutting cycle.
Tissue retrieval mechanism 260 can be is positioned in relation to sample
tube 206 just distal of tissue stop 212 (FIG. 23). As shown in greater
detail in FIGS. 21, 22, and 23, tissue retrieval mechanism 260 includes a
retractable outer sleeve 262. Outer sleeve 262 is pneumatically sealed by
o-rings 263 to maintain vacuum within sample tube 206 during the cutting
cycle. To remove a tissue sample from tube 206 following a cutting cycle,
outer sleeve 262 is manually rotated or translated out of position using
pull-tab 270 to expose the tissue sample in tissue lumen 210. A tissue
retrieval window 264 can be formed in tissue lumen 210 beneath outer
sleeve 262 to provide access to the tissue sample in the lumen once the
outer sleeve is retracted. An air inlet 265 can be located distal of
tissue retrieval window 264 to apply air pressure to the distal face of
the tissue sample 204 in the window, to prevent distal movement of the
sample when outer sleeve 262 is retracted due to a pressure imbalance on
tissue sample 204. A lower cylinder 266 on retractable sleeve 262 can
house a return spring 258 for biasing the sleeve into the closed, sealed
position. Each end of the spring 258 is secured to the retrieval
mechanism 260 with pins 224. The proximal end of tissue retrieval
assembly 260 can include a vacuum attachment 268 for providing vacuum to
tissue lumen 210, such as from vacuum source 36. Vacuum attachment port
216 can also be provided to extend through retrieval mechanism 260 to
provide vacuum to lumen 214, such as from vacuum source 36. At the end of
a procedure, tissue retrieval assembly 260 may be disconnected from
sample tube 206 so that tissue samples may be retrieved from the tube, as
will be described in further detail below.

[0119] As an alternative or in combination with real-time sample retrieval
through tissue retrieval assembly 260, tissue samples may be retrieved at
the end of a procedure by disconnecting sample tube 206 from probe
assembly 32 and removing tissue retrieval assembly 260 from the proximal
end of tissue lumen 210. After sample tube 206 is disconnected, a sample
releasing mechanism such as, for example, the flexible rod such as
plunger-like component 278 shown in FIG. 24, may be inserted in one end
of tissue lumen 210 and advanced there through to extract the samples
from the opposite end of the lumen as shown in FIG. 25. Alternatively,
the tissue sample tube may be formed such that vacuum lumen 214 is
separable from tissue lumen 210 at the conclusion of the procedure to
allow access to the tissue samples stacked within the tissue lumen.

[0120] FIGS. 26a-26c illustrate one embodiment for a separable sample
storage tube in which a dual lumen tube 280 is extruded with weakened
sides along the exterior of tissue lumen 210, as indicated by reference
numeral 282, so that a portion of the lumen 210 is separable, such as by
peeling, to expose tissue samples. When opposite forces are applied to
lumens 210, 214, the two lumens can be peeled apart at the weak points
282, with the upper portion of tissue lumen 210 separating with vacuum
lumen 214 as shown in FIG. 26b. The remaining, lower portion of tissue
lumen 210 will form an open U-channel containing the stacked tissue
samples (U-channel shown in FIG. 26c). The samples may be removed from
the opened tissue lumen 210 using a forceps or other instrument.

[0121] As an alternative to extruding the sample tube with weakened side
points 282, tissue and vacuum lumens 210, 214 could be extruded
separately and assembled together to form a dual lumen tube 284, an
example of which is shown in FIG. 27a. In this embodiment, vacuum lumen
214 is extruded to include the upper portion of tissue lumen 210 so that
tissue lumen 210 forms an open U-channel. The tissue and vacuum lumens
210, 214 are joined along the upper edges 286 of the U-channel by an
adhesive or other type of fastening mechanism. To access the tissue
samples, opposite forces are applied to tube 284 to break the adhesive
bond or other fastening means and peel vacuum lumen 214 away from tissue
lumen 210, as shown in FIG. 27b. The samples may then be removed from the
open tissue lumen.

[0122] In yet another embodiment for a separable sample storage tube,
shown in FIG. 28, a dual lumen tube 290 is formed by joining separately
extruded vacuum and tissue lumens 210, 214. In this embodiment, vacuum
lumen 214 is formed as a closed piece having at least one pair of
laterally extending teeth 292. Tissue lumen 210 is formed as an open
U-shaped channel having a corresponding number of pairs of laterally
extending notches 294 along the inner surfaces of the channel. Teeth 292
are shaped to engage notches 294 to form a mechanical latch 296 that
locks vacuum lumen 214 and tissue lumen 210 together to form the sample
tube. Pulling vacuum lumen 214 in an opposite direction away from tissue
lumen 210 will disengage teeth 292 from notches 294, thereby opening the
top of the tissue lumen to remove tissue samples. Mechanical latch 296
may be used in combination with an adhesive or other attachment mechanism
to lock the vacuum and tissue lumens together.

[0123] FIGS. 29 and 30 illustrate an alternative embodiment for serial
tissue stacking assembly 190 where sample storage tube 206 is replaced
with a separable sample storage tube shown in FIGS. 26-28. In addition,
the tissue retrieval mechanism 260 is replaced with a tissue lumen peel
tab 272. A tissue stop feature is located in lumen peel tab 272 at the
proximal end of tissue lumen 210. A tubing connector 274 connects the
proximal end of vacuum lumen 214 to an axial vacuum line, such as a
vacuum line 42 communicating with vacuum source 36. In this embodiment,
tissue samples are stacked distally from the tissue stop. The tissue
samples 204 can be removed real time by peeling the tissue lumen from the
vacuum lumen 214. Alternately, the tissue samples can be removed at the
conclusion of the procedure.

[0124] FIGS. 31a-31d illustrate the advanced and retracted positions of
lower connector 198, tissue lumen 210 and rod 230 for the initial two
cutting cycles of a biopsy procedure. As shown in FIG. 31a, when cutter
100 is advanced to a fully distal position, i.e. completely through
tissue receiving port 86, tissue lumen 210 is advanced fully distal as
well, with the tissue lumen substantially parallel to outer sleeve 228.
As cutter 100 retracts from tissue receiving port 86 following tissue
cutting, tissue lumen 210 retracts with drive carriage 134 to a proximal
position, as shown in FIG. 31b. In this position, the a distal length
tissue lumen 210 extends downward, such as by flexing, away from outer
sleeve 228. Reciprocating member 242 also retracts and grips the next set
of ratchet teeth 232 on rod 230. During the next cutting cycle, shown in
FIG. 31c, cutter 100 is again fully advanced by drive carriage 134 and
lower connector 198 again pulls tissue lumen 210 distally. As lower
connector 198 is pulled distally, engagement pawls 250 pull on ratchet
teeth 232 of rod 230 to advance the rod through vacuum lumen 214 and out
opening 234. At the conclusion of the second cutting cycle, tissue lumen
210 is again retracted proximally as shown in FIG. 31d.

[0125]FIG. 32 illustrates an alternative embodiment for tissue storage
assembly 52, in which the storage assembly comprises a parallel tissue
stacking assembly 300. In parallel tissue stacking assembly 300, tissue
samples are stored one beside the next in a tissue storage component and
removed at the end of the procedure. As shown in FIGS. 32 and 33,
parallel stacking assembly 300 comprises a tissue storage component 302
containing a series of side-by-side lumens 304. Each of the lumens 304 is
slightly longer than the length of tissue receiving port 86 for storing
tissue samples aspirated from the receiving port. Component 302 may be
comprised of a clear plastic material to allow visual inspection of the
tissues samples stored therein. An integrated knock-out pin 306, (FIG.
34), can be provided at the proximal end of each tissue lumen 304 to
prevent tissue samples from translating completely through the lumen and
into vacuum system 36, while providing vacuum to be communicated to a
lumen (e.g. each knockout pin 306 can include a small central opening
large enough to provide flow communication for providing vacuum to lumen
304, but small enough to not allow a tissue sample to pass out the distal
end of lumen 304.)

[0126] Returning to FIGS. 32 and 33, a tissue tube 308 having a tissue
lumen 310 therein, extends distal of component 302 to connect with tube
152 in probe 32. Tubes 152 and 308 can be aligned to provide a
continuous, generally straight line passageway from lumen 104 of cutter
100 to a lumen 304 in component 302. An O-ring seal 312, shown in FIG.
35, can be provided at the proximal end of tissue tube 308 to seal the
passageway between tissue lumen 310 and the lumen 304 aligned with tube
308. Sample and tissue tubes 152, 308 may be detachably connected by any
suitable type of fastening mechanism such as, for example, snap fasteners
similar to those shown in FIGS. 15a and 15b. A first vacuum port 314 can
be located on the proximal side of component 302 to provide vacuum to
tissue lumen 310 through the lumen 304 aligned with tube 308. A second
lateral vacuum port 316 can be employed to provide vacuum to tissue lumen
310 at a position distal of component 302. Each of vacuum ports 314, 316
can be attached to vacuum source 36 through an axial vacuum line 42 to
provide vacuum for drawing tissue proximally in lumen 104 of cutter 100.
Lateral vacuum port 316 can be attached to a vacuum chamber 320 that
surrounds tissue tube 308. Tissue tube 308 can include a plurality of
spaced holes within vacuum chamber 320 for communicating vacuum between
the chamber and tube lumen 310. Lateral vacuum port 316 and chamber 320
provide additional vacuum for aiding in the proximal movement of a tissue
sample (such as in the case where a tissue sample fragments into multiple
pieces during sampling).

[0127] After a tissue sample is stored in a lumen 304, component 302 can
be indexed laterally to axially align the next adjacent lumen with tissue
lumen 310. As shown in FIG. 33, a cam member 322 is provided for indexing
component 302. Cam member 322 is located in a housing 324 that extends
beneath component 302. Cam member 322 is operatively connected to drive
carriage 134 in probe assembly 32 to translate distally and proximally
with the drive carriage during each cutting cycle. Cam member 322 is
attached to drive carriage 134 by a mechanical cable 326 that extends
distally through an end cap 330. Cable 326 is attached to drive carriage
134 and pulls cam member 322 distally as the drive carriage 134 moves
distally. As cam member 322 moves, a camming surface 332 on the cam
member interacts with bosses 334 (shown in FIG. 34) on the under surface
of component 302 to index component 302. Camming surface 332 can comprise
an angled, flexible strip of material that is deflected by bosses 334. As
shown in FIG. 36a, camming surface 332 is in a non-deflected position
between two bosses, identified by phantom bosses 336, 338, when cam
member 322 is in a proximal-most position prior to a cutting cycle. As
cam member 322 advances distally at the beginning of a cutting cycle,
camming surface 332 is deflected out of position by the contact between
boss 336 and a first side of the camming surface. As cam member 322
continues to advance distally, boss 336 deflects camming surface 332 to a
point at which the boss passes through an opening created between the cam
surface and a stop block 340, as shown in FIG. 36b. After boss 336 passes
through the opening created by the deflecting camming surface, the
camming surface springs back into a non-deflected position in contact
with stop block 340.

[0128] When drive carriage 134 begins to retract following the cutting of
tissue, a return spring 224 within the distal end of housing 324 pushes
cam member 322 proximally within the housing. As cam member 322 retracts
proximally, the opposite side of camming surface 332 contacts boss 336.
As cam member 322 continues to retract, the angle in camming surface 332
causes boss 336 to be pushed laterally, as shown in FIG. 36c. As boss 336
is pushed laterally, component 302 is indexed laterally relative to
tissue tube 308, thereby positioning the next adjacent lumen 304 to
receive the next tissue sample through tube 308. As shown in FIGS. 32 and
33, component 302 is positioned between cam member housing 324 and a
detent arm 342. Detent arm 342 extends distally across the upper surface
of component 302. As component 302 is indexed laterally by the
interaction of camming surface 332 and boss 336, detent arm 342 engages
one of a series of indexing detents 344. Indexing detents 344 lock the
next active lumen 304 into alignment with lumen 310 following each
indexing action. The plurality of bosses 334 and indexing detents 344
enable component 302 to be repetitively indexed to store a plurality of
tissue samples during a biopsy procedure. At the conclusion of a biopsy
procedure, component 302 may be removed from between housing 324 and
detent arm 342, and the tissue samples removed from the individual tissue
lumens 304. The top surface of component 302 can include a cover or other
removable portion to allow each sample to be easily removed from the
lumens 304.

[0129]FIG. 37 is an exploded isometric view of an exemplary drive
assembly 350 for holster 34. In the assembly shown in FIG. 37, the
translation and rotation drive trains (for providing rotation and
translation of cutter 100) are driven by a single rotatable cable 55
(also shown in FIG. 1) that extends between holster 34 and a remotely
located motor, such as a motor in control module 46. A single drive cable
is capable of rotating both drive trains due to the reduced cutter stroke
of the present invention. The reduced cutter stroke enables the size of
handpiece 30, as well as the load on the drive motor, to be reduced
relative to previous biopsy devices. Powering handpiece 30 through a
single rotatable cable enables the handpiece to be utilized in MRI guided
procedures since ferromagnetic motor components are separated from the
handpiece. The handpiece can also be used in mammography and ultrasound
guided procedures. Accordingly, a common probe assembly and handpiece can
be utilized for multiple imaging environments. For an MRI guided
procedure, the length of the rotatable cable may be increased to
accommodate use near or within an MRI bore.

[0130] In the embodiment shown in FIG. 37, rotatable cable 55 attaches to
a drive cable input coupling 352 for providing rotational drive to
holster 34. A drive shaft 354 from input coupling 352 extends to a
proximal housing 356. Within proximal housing 356, an input gear 360 is
mounted on input drive shaft 354 between spacer 362 and bearing 389 so as
to engage corresponding gears on a translation drive shaft 364 and a
rotation drive shaft 366. The interaction of the input gear 360 with
translation shaft gear 370 and rotation shaft gear 372 transmits the
rotational drive to translation and rotation drive shafts 364, 366.
Translation and rotation drive shafts 364, 366 extend from proximal
housing 356 through a pair of bores in a center housing 374. Translation
and rotation gears 370, 372 are spaced between the proximal and center
housings by bearings 376.

[0131] Distal of center housing 374, holster 34 includes a rotary encoder
380 for providing a feedback signal to control module 46 regarding
rotation of the drive shafts. Encoder 380 may be mounted on either the
translation or the rotation drive shafts. Holster 34 also includes an
optional planetary gearbox 382 on translation drive shaft 364. Gearbox
382 provides a gear reduction between the translation and rotation drive
trains to produce differing speeds for the translation of drive carriage
134 and the rotation of cutter 104. Distal of gearbox 382 and encoder
380, drive assembly 350 includes a housing 384. Housing 384 includes
connections for coupling the translation drive train with translation
drive input shaft 386, and the rotational drive train with rotary drive
input shaft 388. Each of the drive input shafts 386, 388 has a distal end
shaped to operatively engage slots on corresponding drive shafts in probe
assembly 32. In particular, translation drive input shaft 386 is shaped
to engage slot 128 of translation shaft 142 (shown in FIG. 4), and rotary
drive input shaft 388 is shaped to engage slot 132 of rotary drive shaft
114. As mentioned above with respect to FIG. 6, the drive input shafts
may have molded interfaces, rather than the mating slots and tips shown
in FIGS. 4 and 37, to reduce the coupling length between the shafts.
Translation and rotary drive shafts 386, 388 extend distally from housing
384 for engagement with drive and translation shafts 114, 142 when probe
assembly 32 and holster 34 are connected.

[0132] The embodiment shown in FIG. 37 comprises a single drive cable
input for operatively driving the translation and rotation shafts. In an
alternative embodiment, a single motor mounted in the holster 34 can
replace rotatable cable 55. The single motor drives both the translation
and rotation shafts through a suitable gearing assembly. The motor may be
mounted above or proximal to the drive assembly. Another embodiment
replaces the single motor with two motors. One motor would drive the
translation drive input shaft and the other would drive the rotary drive
input shaft.

[0133] In the embodiments described, the cutting stroke length for the
cutter 100 is reduced to slightly longer than the length of tissue
receiving port 86. This stroke reduction is possible in part because
tissue samples are aspirated through the cutter lumen, rather than being
pulled proximally through the needle by a retracting cutter. Reducing the
cutting stroke length has a number of benefits. One of the benefits of a
reduced cutting stroke length is that the overall size and weight of the
probe assembly may be reduced, thereby enabling the biopsy device to be
used in imaging environments where size has traditionally been a
limitation. In particular, the reduced size of the probe assembly enables
an essentially common probe assembly to be used in both open and closed
bore MRI guided procedures, as well as in mammography and ultrasound
procedures, with minor adjustments. A common cable driven holster may
also be used in each of the imaging modalities, with the alternative,
single or double motor embodiments useable in both the mammography and
ultrasound guided procedures. In addition, a common control module can be
used to control the handpiece in any of the three imaging environments.
The probe assembly may be adapted for use in an MRI guided procedure by
utilizing a needle and cutter subassembly that is comprised of a
non-ferromagnetic material, such as a plastic or ceramic, in order to
reduce image artifacts. In addition, the cutter assembly may be removed
from the probe, as described above with respect to FIGS. 7 and 8, for MRI
imaging prior to initiation of a cutting cycle. Alternately, the distal
end of the cutter may be simply retracted proximally from the tissue
receiving port area during imaging.

[0134] To accommodate each of the different imaging modalities, reusable
handpiece base units specific to each of the imaging environments may be
utilized. Each of the handpiece base units may be used for firing and/or
rotating the needle aperture, depending upon the operator's needs and the
constrictions of the particular imaging environment. Each of the base
units is designed to accommodate the probe assembly to enable the same
probe to be used across imaging modalities.

[0135]FIG. 38a illustrates a base 420 for use with probe assembly 32 in a
mammography guided procedure. Base 420 may be attached to the
stereotactic arm of a mammography machine by a mounting feature 422. A
recessed nest area 424 is provided in base 420 for accommodating the
probe lower shell. Probe assembly 32 may be lodged in nest 424 prior to
the initiation of a procedure. A firing button 426 is included in base
420 for firing the needle of the probe assembly into the tissue mass of
interest. A knob 430 on the side of base unit 420 compresses a firing
spring within the unit. When button 426 is compressed, the spring pushes
against probe assembly 32 to forcibly drive the entire probe assembly and
nest 424 forward relative to the mounting feature 422.

[0136] An aperture rotation gear 432 is also provided in the recessed area
of base 420 for rotating the tissue receiving port of the probe assembly
after the needle is positioned within the tissue mass. Aperture rotation
gear 432 includes a plurality of gear teeth 434. Gear teeth 434 project
partially above the recessed surface area to engage similar shaped teeth
on a second gear integral to the needle support component within probe
assembly 32. Teeth on the second, needle gear are recessed within the
probe shell, but accessible by aperture rotation gear 432 when the probe
is lodged in nest 424. A knob 436 is provided on the proximal end of base
420 for manually rotating gear 432. When gear 432 rotates, the engagement
between the gears causes the needle to rotate, thereby repositioning the
tissue receiving port within the tissue mass. Probe assembly 32 can
include flexible engagement fingers that lock the needle gear and prevent
the gear from rotating outside of nest 424. When probe assembly 32 is
inserted into nest 424, the flexible fingers are deflected so as to
disengage from the needle gear, and allow the gear to rotate in response
to the rotation of base gear 432. FIG. 38b illustrates the probe assembly
32 lodged in nest 424.

[0137]FIG. 39 illustrates a similar type of probe base unit for use in an
ultrasound imaging environment. As shown in FIG. 39, the base unit 440
includes a nest 442 for accommodating the lower shell of probe assembly
32. A knob 444 is provided for compressing a firing spring within base
440, as well as a button 446 for releasing the spring to "fire" the probe
assembly and nest 424 into a tissue mass. In the ultrasound environment,
base 440 may be hand-held and manipulated as required by the operator.
Accordingly, a needle rotation mechanism is not necessary for base 440,
since the operator may rotate the needle by manually rotating the base
and/or probe assembly.

[0138] As shown in FIG. 40, a third type of probe base 450 is provided for
use in MRI guided procedures. Base 450 may be mounted to a localization
unit within the MRI unit. The reduced size of the probe assembly in the
present invention reduces the structural requirements for the
localization unit due to the reduced cantilever loading generated by the
probe. MRI base 450 includes a recessed nest 452 for accommodating the
lower probe shell. In addition, the base includes an aperture rotation
gear 454 having a plurality of gear teeth that engage similar shaped
teeth that extend from the probe lower shell. The gear in the lower probe
shell is attached to the needle to rotate the needle whenever gear 454 is
rotated, in a manner similar to the mammography nest embodiment shown in
FIG. 38. An aperture rotation knob 456 is located on the proximal end of
base 450 to manually rotate gear 454 and, correspondingly, the tissue
receiving aperture in the needle. Base 450 does not require a firing
mechanism for positioning the needle within the tissue. However, multiple
needle lengths may be used with the probe assembly to enable the probe
assembly to more easily fit within the MRI unit. The particular needle
length selected will depend upon the depth of the tissue mass of interest
within the patient's body.

[0139] As an alternative to the use of MRI base 450, an MRI localization
depth gage 460, such as shown in FIG. 41, may be used for positioning the
probe assembly. In this embodiment, a depth stop 462 is attached to the
probe assembly and/or the needle 80. The depth stop includes an
adjustment knob 464 for adjusting the desired depth of the probe needle.
After the needle is properly positioned, the probe is inserted into the
patient's tissue until the stop is reached. The patient may then be
placed in the MRI device and imaged without additional support for the
probe assembly. After the needle position within the tissue is confirmed,
the holster is attached to the probe assembly to begin tissue sampling.

[0140] While preferred embodiments of the present invention have been
shown and described herein, it will be obvious to those skilled in the
art that such embodiments are provided by way of example only. Numerous
variations, changes, and substitutions will now occur to those skilled in
the art without departing from the spirit and scope of the appended
claims. Additionally, each element described in relation to the invention
can be alternatively described as a means for performing that element's
function.

[0141] It should be understood that any one or more of the teachings,
expressions, embodiments, examples, etc. described herein may be combined
with any one or more of the other teachings, expressions, embodiments,
examples, etc. that are described herein. The following-described
teachings, expressions, embodiments, examples, etc. should therefore not
be viewed in isolation relative to each other. Various suitable ways in
which the teachings herein may be combined will be readily apparent to
those of ordinary skill in the art in view of the teachings herein. Such
modifications and variations are intended to be included within the scope
of the claims.

[0142] Having shown and described various embodiments of the present
invention, further adaptations of the methods and systems described
herein may be accomplished by appropriate modifications by one of
ordinary skill in the art without departing from the scope of the present
invention. Several of such potential modifications have been mentioned,
and others will be apparent to those skilled in the art. For instance,
the examples, embodiments, geometrics, materials, dimensions, ratios,
steps, and the like discussed above are illustrative and are not
required. Accordingly, the scope of the present invention should be
considered in terms of the following claims and is understood not to be
limited to the details of structure and operation shown and described in
the specification and drawings.